Publishing of Clinical Trial and Regulatory Submission Documents

Regulatory Publishing Expertise to Support Electronic Submissions to Regulatory Authorities

Health Authorities around the world are requiring that all clinical trial documentation, as well as regulatory and marketing applications be submitted electronically. This improves the efficiency of delivery, formatting, and review of the files, documentation, and applications submitted.

Sponsors sometimes fail to understand the time and effort involved in pre-flighting and publishing their submissions to regulatory agencies (i.e., submitting to the FDA over the electronic submissions gateway (ESG)). At Veristat, we understand the critical nature of publishing to health authorities and that is why we’ve assembled an experienced team of regulatory publishers who average 10-14 years of industry publishing experience.

Ensure a successful regulatory submission process.

Our regulatory publishing experts will help you establish realistic timelines and best practices for publishing single documents or full marketing applications. Using the right publishing team that is fully integrated with your regulatory and writing teams can help you find efficiencies to reduce timelines. Whether you are just beginning your development process or are not happy with your current publishing partner – we can help.

All submissions are electronically published to regulatory agencies using an industry-leading technology platform with templates that our publishers have customized to meet the real-world needs of our customers.

A Proven Regulatory Publishing Process

Pre-Publish

Document-level processing. Includes document formatting in our templates as mentioned, converting to PDF, and ensuring the appropriate bookmarks and internal hyperlinks are present to meet eCTD guidance